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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, continuous, facility use
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH 207, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
COSMED S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 3
DRAEGER MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 2
DRAGER MEDICAL AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
EVENT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
EVENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 4
FLIGHT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 18
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
INOVYTECH MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEVEL-5, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 4
NEWPORT MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
PAN-AMERICA HYPERBARICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE GLOBAL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PULMONETIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS CALIFORNIA, INC.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECME S.A.
  SUBSTANTIALLY EQUIVALENT 2
VENTEC LIFE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VERSAMED MEDICAL SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 2
VERSAMED MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 7596 7596
2015 11874 11874
2016 16056 16056
2017 14451 14451
2018 9849 9849
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 6744 6744

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 15343 15343
Mechanical Problem 12550 12550
Device Operates Differently Than Expected 9862 9862
Output Problem 9411 9411
No Display/Image 8309 8309
Circuit Failure 7085 7085
Battery Problem 6367 6401
Device Inoperable 6042 6042
Failure to Recalibrate 4767 4767
Failure to Charge 4581 4597
Failure to Run on Battery 3918 3918
Defective Component 3829 3829
Failure to Calibrate 3800 4066
Failure to Power Up 3616 3616
Electrical /Electronic Property Problem 3287 3287
Incorrect Or Inadequate Test Results 2611 2611
Display or Visual Feedback Problem 2494 2494
Device Operational Issue 2347 2347
Failure of Device to Self-Test 2332 2332
Appropriate Term/Code Not Available 2086 2086
Protective Measures Problem 2060 2099
Gas/Air Leak 2028 2028
Improper Flow or Infusion 1852 1852
Power Problem 1789 1831
Degraded 1648 1648
Leak/Splash 1558 1558
Insufficient Information 1465 1465
No Flow 1427 1427
Device Alarm System 1417 1417
Contamination 1403 1403
Failure to Deliver 1390 1390
Infusion or Flow Problem 1306 1306
Unexpected Shutdown 1293 1293
Pressure Problem 1179 1179
Loss of Power 1158 1158
Erratic or Intermittent Display 1151 1151
Adverse Event Without Identified Device or Use Problem 1141 1141
Calibration Problem 1126 1126
Decrease in Pressure 1067 1067
Break 858 858
Communication or Transmission Problem 822 822
Gas Output Problem 814 814
Insufficient Flow or Under Infusion 796 796
Tidal Volume Fluctuations 724 724
Inaccurate Delivery 694 694
Therapeutic or Diagnostic Output Failure 682 682
Charging Problem 672 672
Noise, Audible 629 629
Application Program Problem 614 614
Failure to Cycle 598 598
Incorrect, Inadequate or Imprecise Result or Readings 564 564
Complete Loss of Power 517 517
Device Stops Intermittently 514 514
Computer Software Problem 483 483
Connection Problem 470 470
No Audible Alarm 465 465
Inadequate User Interface 454 458
Thermal Decomposition of Device 452 452
Use of Device Problem 415 415
Application Interface Becomes Non-Functional Or Program Exits Abnormally 405 405
Increase in Pressure 380 380
Inappropriate or Unexpected Reset 367 368
Self-Activation or Keying 347 347
Volume Accuracy Problem 340 340
Device Sensing Problem 330 330
Image Display Error/Artifact 325 325
Defective Device 319 319
Disconnection 310 310
Reset Problem 298 298
Premature Discharge of Battery 295 295
Computer Operating System Problem 289 289
Smoking 283 283
Loose or Intermittent Connection 274 274
Excess Flow or Over-Infusion 258 258
Defective Alarm 258 258
Device Maintenance Issue 248 248
Occlusion Within Device 247 247
Temperature Problem 240 240
Poor Quality Image 217 217
Alarm Not Visible 215 215
Aborted Charge 213 213
Contamination /Decontamination Problem 212 212
Peeled/Delaminated 211 211
Medical Gas Supply Problem 199 199
Obstruction of Flow 195 195
False Positive Result 194 194
No Pressure 184 184
Device Emits Odor 179 179
Low Readings 177 177
Ventilation Problem in Device Environment 174 174
Detachment of Device or Device Component 172 172
Suction Problem 165 165
Fracture 162 162
Overheating of Device 159 159
Failure to Conduct 159 159
Crack 148 148
Operating System Becomes Nonfunctional 145 145
Mechanical Jam 139 139
Unexpected Therapeutic Results 135 135
Nonstandard Device 134 134

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58804 58804
No Patient Involvement 37609 37610
No Consequences Or Impact To Patient 25166 25567
No Known Impact Or Consequence To Patient 10951 10953
No Information 2951 2951
Insufficient Information 1638 1638
Low Oxygen Saturation 1285 1286
No Code Available 1161 1161
Death 725 725
Dyspnea 258 258
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 255 255
Unspecified Respiratory Problem 229 229
Cardiac Arrest 187 187
Headache 169 169
Respiratory Failure 165 165
Respiratory Insufficiency 121 121
Respiratory Distress 120 120
Hypoxia 106 106
Bradycardia 106 106
Respiratory Tract Infection 86 86
Cough 83 83
Ventilator Dependent 80 80
Cyanosis 78 78
Sore Throat 76 76
Dizziness 72 72
Pneumothorax 71 71
Hypoventilation 55 55
Patient Problem/Medical Problem 52 52
Nausea 47 47
Low Blood Pressure/ Hypotension 45 45
Loss of consciousness 41 41
Injury 40 40
Respiratory Arrest 40 40
Apnea 40 40
Cardiopulmonary Arrest 40 40
Pneumonia 39 39
Cancer 37 37
Discomfort 33 33
Increased Respiratory Rate 32 32
Tachycardia 29 29
Vomiting 28 28
Unspecified Kidney or Urinary Problem 27 27
Skin Inflammation/ Irritation 26 26
Asthma 26 26
Respiratory Acidosis 23 23
Chest Pain 20 20
Chronic Obstructive Pulmonary Disease (COPD) 20 20
Hypersensitivity/Allergic reaction 19 19
Unspecified Infection 17 17
Inflammation 17 17
Burn(s) 15 15
Abnormal Blood Gases 15 15
Unspecified Eye / Vision Problem 15 15
Unspecified Heart Problem 15 15
Complaint, Ill-Defined 13 13
Hyperventilation 13 13
Anxiety 13 13
High Blood Pressure/ Hypertension 12 12
Heart Failure/Congestive Heart Failure 12 12
Epistaxis 11 11
Unspecified Hepatic or Biliary Problem 11 11
Urinary Retention 11 11
Pain 11 11
Fatigue 10 10
Stacking Breaths 10 10
Nodule 10 10
Bowel Perforation 10 10
Decreased Respiratory Rate 9 9
Extubate 9 9
Stroke/CVA 9 9
Distress 9 9
Brain Injury 8 8
Renal Failure 8 8
Dry Eye(s) 8 8
Coma 8 8
Swelling/ Edema 8 8
Electric Shock 7 7
Aspiration/Inhalation 7 7
Rash 7 7
Perforation 7 7
Liver Damage/Dysfunction 7 7
Burning Sensation 7 7
Myocardial Infarction 6 6
Airway Obstruction 6 6
Encephalopathy 6 6
Fever 6 6
Fall 6 6
Hemorrhage/Bleeding 6 6
Lethargy 6 6
Sleep Dysfunction 6 6
Cognitive Changes 6 6
Confusion/ Disorientation 6 6
Foreign Body In Patient 6 6
Partial thickness (Second Degree) Burn 6 6
Convulsion/Seizure 6 6
Thrombosis/Thrombus 5 5
Inadequate Osseointegration 5 5
Diminished Pulse Pressure 5 5
Overinflation of Lung 5 5
Hemoptysis 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Feb-24-2023
2 Biomed Devices II Jan-27-2011
3 Breas Medical, Inc. II Apr-15-2022
4 COVIDIEN LLC I Dec-18-2018
5 CareFusion 203, Inc. I Sep-19-2014
6 CareFusion 203, Inc. I Jul-16-2012
7 CareFusion 203, Inc. I Oct-26-2011
8 CareFusion 203, Inc. II Aug-10-2010
9 CareFusion 203, Inc. II Feb-25-2010
10 Carefusion 211 Inc I Jan-11-2012
11 Carefusion 211 Inc dba Carefusion I Jun-13-2016
12 Carefusion 211 Inc dba Carefusion I May-26-2015
13 Carefusion 211 Inc dba Carefusion I Sep-27-2013
14 Covidien I Jan-03-2014
15 Covidien LLC II Mar-27-2018
16 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
17 Covidien LP (formerly Nellcor Puritan Bennett Inc.) I Aug-14-2015
18 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Feb-05-2015
19 Covidien Llc II Nov-06-2020
20 Covidien, LP I Dec-09-2021
21 Datex-Ohmeda, Inc. II Aug-08-2018
22 Datex-Ohmeda, Inc. II Jun-01-2018
23 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
24 Del Mar Reynolds Medical, Ltd. II Apr-20-2015
25 Del Mar Reynolds Medical, Ltd. I Apr-12-2014
26 Del Mar Reynolds Medical, Ltd. II Jul-19-2013
27 Del Mar Reynolds Medical, Ltd. I Mar-20-2013
28 Draeger Medical Systems, Inc. I Mar-28-2014
29 Draeger Medical Systems, Inc. II Oct-07-2010
30 Draeger Medical, Inc. I Aug-18-2023
31 Draeger Medical, Inc. I Jul-08-2023
32 Draeger Medical, Inc. I Feb-24-2023
33 Draeger Medical, Inc. II Apr-04-2022
34 Draeger Medical, Inc. II Oct-14-2021
35 Draeger Medical, Inc. II May-28-2021
36 Draeger Medical, Inc. II May-29-2018
37 Draeger Medical, Inc. I Aug-04-2016
38 Draeger Medical, Inc. I Feb-25-2016
39 Draeger Medical, Inc. I Feb-03-2016
40 Draeger Medical, Inc. I Dec-23-2015
41 Draeger Medical, Inc. I Aug-14-2015
42 Draeger Medical, Inc. II May-14-2009
43 Event Medical LTD I Nov-19-2015
44 Flight Medical Ltd. I Feb-21-2012
45 GE Healthcare II Mar-24-2015
46 GE Healthcare, LLC I Jun-06-2022
47 GE Healthcare, LLC II Aug-24-2020
48 GE Healthcare, LLC II Dec-17-2019
49 GE Healthcare, LLC I Nov-30-2018
50 GE Healthcare, LLC I Jun-17-2012
51 GE Medical Systems, LLC II Jan-21-2016
52 Getinge Group Logistics America, LLC II Oct-09-2020
53 Getinge Usa Sales Inc II Aug-24-2022
54 Getinge Usa Sales Inc I Aug-22-2022
55 Hamilton Medical AG II Apr-25-2023
56 Hamilton Medical AG II Nov-18-2022
57 Hamilton Medical AG I Aug-19-2022
58 Hamilton Medical AG I Jul-11-2019
59 Hamilton Medical AG II Aug-14-2018
60 Hamilton Medical AG II Apr-12-2018
61 Hamilton Medical Inc I Jan-31-2013
62 Hamilton Medical Inc II Mar-07-2012
63 Hamilton Medical Inc II Apr-08-2011
64 Hamilton Medical, Inc. I Sep-20-2023
65 Hamilton Medical, Inc. I Jul-21-2023
66 Hamilton Medical, Inc. II Nov-28-2016
67 Hamilton Medical, Inc. II May-09-2016
68 Hamilton Medical, Inc. I Nov-04-2015
69 Hamilton Medical, Inc. II Jul-10-2015
70 Hamilton Medical, Inc. II Nov-06-2013
71 Hill-Rom Manufacturing, Inc. II Nov-24-2020
72 Impact Instrumentation, Inc. III Aug-07-2012
73 Impact Instrumentation, Inc. II Aug-29-2011
74 MAQUET Inc. II Jan-05-2010
75 MAQUET Inc. II May-12-2009
76 MAQUET Inc. II Feb-03-2009
77 Maquet Cardiovascular Us Sales, Llc I Apr-26-2013
78 Maquet Inc. II Apr-03-2012
79 Maquet Inc. II Dec-02-2011
80 Maquet Inc. II Jun-23-2011
81 Medtronic formerly Covidien I Apr-25-2022
82 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
83 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Dec-09-2014
84 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Oct-28-2014
85 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-20-2014
86 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-17-2014
87 Nellcor Puritan Bennett Inc. (dba Covidien LP) II May-09-2014
88 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jan-24-2014
89 Newport Medical Instruments Inc I Apr-10-2017
90 Newport Medical Instruments Inc I Apr-14-2014
91 Newport Medical Instruments Inc I Apr-26-2013
92 Newport Medical Instruments Inc II Jun-08-2011
93 Newport Medical Instruments Inc II Jun-02-2011
94 Newport Medical Instruments Inc II May-27-2011
95 Newport Medical Instruments Inc II May-26-2011
96 Newport Medical Instruments Inc II May-26-2011
97 Newport Medical Instruments Inc II May-19-2010
98 Newport Medical Instruments Inc II Sep-04-2009
99 Percussionaire Corporation I Jan-17-2024
100 Percussionaire Corporation I Jan-17-2024
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